Calcium Sulfate Based Bioactive Bone Graft

硫酸钙基生物活性骨移植物

• 批准号: 7394870
• 负责人: Harold Alexander
• 金额: $ 38.29万
• 依托单位: ORTHOGEN, LLC
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-08 至 2010-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7394870
• 关键词: Allografting; Anhydrides; Animal Model; Anti-Inflammatory Agents; Anti-inflammatory; Aspirin; Autologous Transplantation; Becaplermin; Benign; Biocompatible; Bioglass; Blood Vessels; Bone Growth; Bone Morphogenetic Proteins; Bone Regeneration; Bone Transplantation; Calcium Sulfate; Cells; Chemical Structure; Collagen; Cultured Cells; Defect; Dental; Dental Implants; Dentistry; Dentists; Development; Effectiveness; Environment; Esters; Excision; Face; Feasibility Studies; Filler; Fracture; Growth Factor; Harvest; Hemostatic Agents; Human; In Vitro; Jaw; Kinetics; Maintenance; Malignant Neoplasms; Marketing; Marrow; Mesenchymal; Methylene Chloride; Non-Steroidal Anti-Inflammatory Agents; Oral; Organ Transplantation; Orthopedics; Osteogenesis; Patients; Periodontal Diseases; Periodontal Pocket; Phase; Phase I Clinical Trials; Platelet-Derived Growth Factor; Polymers; Procedures; Process; Property; Public Health; Rate; Recombinants; Recording of previous events; Research; Safety; Salicylic Acid; Salicylic Acids; Sinus; Stem cells; Tissues; Tooth Loss; Transplanted tissue; United States Food and Drug Administration; Week; Work; allogenic bone transplantation; base; bone; bone growth factor; bone morphogenetic protein 7; calcium phosphate; concept; improved; in vivo; interest; maxillofacial; new growth; recombinant human bone morphogenetic protein-2; response; septic; tricalcium phosphate; vasculogenesis

DESCRIPTION (provided by applicant): The aim of this research is to develop an improved, synthetic bone graft material for use in dentistry. The loss of teeth is often accompanied by the loss of jaw bone. Restoring this lost bone is often a prerequisite for the installation of dental implants and the maintenance of normal facial features. Calcium sulfate works quite well as a bone regeneration material. It serves not only as a defect filler, but is also biocompatible, conducts new bone growth and encourages the growth of new blood vessels. However, its fast degradation is its major shortcoming, restricting its use in bone grafting applications. Based upon a successful phase I feasibility study, this project proposes the development of a new material: a calcium sulfate/absorbable polymer composite with anti-inflammatory properties and bone growth factor delivery capability. Phase I studies have already demonstrated that calcium sulfate/ absorbable polymer composites undergo slower degradation than pure calcium sulfate and thus overcomes a significant drawback of this material as a bone regeneration product. The plan now is to develop a product that dentists can use in bone grafting procedures that will rival the bone regeneration potential seen with the use of the patients own harvested bone. The product, a composite of calcium sulfate and Poly-Aspirin that delivers a bone growth factor, PDGF, utilizes a new polymer whose in vivo bone response has been studied in several animal models. Because of its specific chemical structure, this polymer elicits an excellent cell and tissue response and has an anti-inflammatory effect of great value in the oral environment. Since an earlier version of this product has already been commercialized, this new product will be rapidly introduced to the marketplace and an improved replacement. PUBLIC HEALTH RELEVANCE: Bone grafting is an essential component of facial and dental maintenance. Recent concern about allograft bone supply makes the development of a reliable, affordable synthetic essential to this process. This project describes the development of just such a synthetic with bone regeneration capability rivaling autografts based on a simple, affordable material with a long safety history, calcium sulfate, combined with an anti-inflammatory absorbable polymer and a bone growth factor.

描述（由申请人提供）：这项研究的目的是开发改进的合成骨移植物材料以用于牙科。牙齿的损失通常伴随着颌骨的损失。恢复这种失去的骨头通常是安装牙科植入物和维护正常面部特征的先决条件。硫酸钙作为骨再生材料的效果很好。它不仅可以用作缺陷填充物，而且还具有生物相容性，可以进行新的骨骼生长，并鼓励新血管的生长。但是，其快速降解是其主要缺点，限制了其在骨移植应用中的使用。基于成功的I期可行性研究，该项目提出了一种新材料的开发：硫酸钙/可吸收的聚合物复合材料具有抗炎特性和骨生长因子递送能力。第一阶段的研究已经证明，硫酸钙/可吸收的聚合物复合材料的降解比纯硫酸钙慢，从而克服了该材料作为骨再生产物的显着缺陷。现在的计划是开发一种牙医可以在骨移植程序中使用的产品，该产品将与使用患者自己的收获骨相媲美的骨再生潜力。该产物是硫酸钙和多峰蛋白的复合物，可提供骨生长因子，PDGF使用了一种新的聚合物，其在几种动物模型中已经研究了体内骨反应。由于其特定的化学结构，该聚合物会引起出色的细胞和组织反应，并在口服环境中具有巨大价值的抗炎作用。由于该产品的较早版本已经商业化，因此该新产品将迅速引入市场并改进了替代品。 公共卫生相关性：骨移植是面部和牙齿维护的重要组成部分。最近对同种异体骨供应的关注使得开发了这一过程的可靠，负担得起的合成。该项目描述了基于较长的安全史的简单，负担得起的材料（硫酸钙）与抗炎吸收性聚合物和骨生长因子相结合的简单，负担得起的材料，与骨再生能力的发展相媲美。